Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection

Colorectal Surgery Clinical Trial

Official title:

Transrectal Vacuum Assisted Drainage: A NEW METHOD OF TREATING ANASTOMOTIC LEAKAGE AFTER RECTAL RESECTION. A Prospective Randomized Multicenter Study in Cooperation With "The Danish Colorectal Cancer Group"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00773981
• Other study ID #: H-B-2007-061
• Status: Recruiting
• Phase: Phase 3
• First received: October 15, 2008
• Last updated: November 3, 2008
• Start date: October 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2008
• Source: Hvidovre University Hospital
• Contact: Carl F Nagell, MD
• Phone: + 45 44443343
• Email: rikke.frederik[@]dadlnet.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Anastomotic leakage is a major and potentially mortal complication with an incidence of 10-13% after resection of the rectum. For patients showing no clinical signs of peritonitis, the traditional method has been a conservative treatment with transrectal rinsing. This treatment is often associated with a very protracted postoperative course with healing times of up to a year or more for the anastomotic leakage.

Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy.

The objective of this study is to investigate the effects of transrectal vacuum treatment on the healing of anastomotic leakage after rectum resection in a prospective, randomized, controlled multicentre trial in 60 patients found to develop clinically significant anastomotic leakages after elective rectal resection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with clinically significant* anastomotic leakage after intended curative rectal resection (LAR) for rectal cancer with primary anastomosis.

• Patients whose operation did not include ileostomy must have surgery to create a stoma within two days after beginning of the vacuum therapy and before randomization. Anastomotic leakage must have been diagnosed within 21 days of the primary operation.

• Patients with and without preoperative radiation therapy may participate.

• Groups will be formed accordingly, because patients who had preoperative radiation therapy heal more slowly.

• Patients with anastomotic leakage (diagnosed by endoscopic or radiology techniques) and clinical signs and symptoms indicating a health impairment (fever, pain, elevated creatinine levels).

• Anastomotic leakage after rectal cancer surgery

Exclusion Criteria:

• Informed consent

• Age < 18 years

• Acute surgery

• Leakage diagnosed more than 21 days after the primary operation

• Patient does not consent to temporary ileostomy

• Anastomosis technically inaccessible for vacuum-assisted drainage

• Small intestine visible in abscess cavity

• Residual cancer tissue in the pelvic cavity

• Suspicion of fistulation between the abscess cavity and internal genitalia, urinary tract system, or small intestines.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Colorectal Surgery

Intervention

Procedure:
• Transrectal vacuum assisted drainage
Treatment with vacuum drainage (VD) is a new method primarily developed for wound therapy. The principle of the method is application of negative pressure on the wound surface with the help of a sponge that is connected to a pump. Sponge dressings should be changed 3 times pr week as long as vacuum therapy is used. If there has been no development of granulation tissue or no shrinking of the cavity in 3 weeks Vacuum therapy can be stopped. Maximum vacuum therapy is 8 weeks.

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Braun Aesculap

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time of the anastomotic leakage		1 year	No
Secondary	Salvage surgery (abdominal reoperation with debridement of anastomosis)		1 month	No
Secondary	Duration of fever and antibiotic treatment		2 months	No
Secondary	Duration of hospital stay		2 monts	No
Secondary	Number of visits in the outpatient clinic / number of sponge changes		8 weeks	No
Secondary	Functional result, defined as +/- closure of temporary ileostomy		2 years	No
Secondary	Functional result evaluated by examination of the anal physiology in a smaller patient population (supplementary trial protocol)		2 years	No